Has anyone quit Incivek before 12 weeks?

[hepcexperiment]

I got to 2 days before my 10th week and had to stop everything. I was crying constantly and had developed a terrible brain fog that made me unable to think clearly or do my 3 day a week job. I worry about lasting neurotoxicity effects. I gained weight even though I stopped eating the 20grams of fat because gaining weight was making me more depressed. I just laid in bed and slept for days and my body has gotten really bloated and swollen, especially my feet and legs. I was a very healthy 52 year old with no hep c symptoms prior to starting treatment. I cleared the virus at 4 weeks, and am hoping that virus is still clear - will know this week.

If anyone out there stopped all treatment before they were supposed to and has still remained clear of the virus, please let me know!! Am also interested in how long side effects last after treatment. Thanks!

[working dog]

have you stopped the interferon and riba too??...my 10th week was hell but i'm doing better this week...i know at the end of week 10 i felt not so great mentally...was on 100 zoloft and bumped it up to 150...i think your sx will go away in a couple months if you stopped all the way...and even if you just stopped the incivek some sx should get better...good luck and keep us posted...billy

[paen53]

What was your degree of liver damage starting out and which genotype? How have your labs been both before and on tx? The swelling and bloating need to be addressed by your Dr if they haven't already.

[HectorSF]

You will feel better in time as the meds affects diminish over time.
It sounds like you had/have a depressive episode. When you treat again you should be on anti-depressants before starting treatment.

Can you achieve SRV by treating for only 9 weeks? No. The virus will come back shortly after stopping all treatment.
The edema (selling) will also reside in time or your doc can give you some meds to flush out the fluid from your system if needed.

No point worrying about post-treatment affects until you overcome your depression and clear the meds from your system. Get back to your routine as soon as you can. Get active. Sleeping all the time can make depression worse. Concentrate on your problems at hand rather than imagining the worst.

Good luck.
Hector

[pcds]

Stopping everything is not a good idea at all.  If you just stopped the telaprevir and continued the peg and riba you might have felt better.  I was told if you completed 8 weeks of telaprevir you might be OK but not cutting out the riba a peg.  Dose reduction discussion with your doc would be wise.  I feel for you, I am suffering too.

[curiouslady1]

You did the best you could do at the time and you have given your liver a little rest.  Now, concentrating on working through your depression and recovering from your other symptoms would seem to be the order of the day.  Whatever, don't bash yourself up any further.  What's done is done.   If your liver is not badly affected by the viral infection perhaps you could wait a few years for newer drugs to appear on the market as others are doing.   These are discussions that you best have with your doc.  

[Willy50]

First, it sounds as if it may have been doctors orders to cease TX.  If you have swelling of the legs I think you need prompt medical attention, bed rest elevated feet, diuretics possibly but please have this checked out by a physician.

I'm just answering w/o looking at your old posts but once upon a time vertex tried treating people with 12 weeks of TX.  If they were clear at possibly 2 and 8 they could stop at 12 weeks (sorry, can't remember the protocol)  It seemed that about 30% were able to SVR (If memory serves).

If you had other positive factors; tx naive, CC phenotype, low staging,  g-2 etc it could be possible that you could succeed, especially if you were actually clear before week 4.  The odds are not great at 10 weeks but i wouldn't say impossible.

The most important thing now is to get medical attention now if you need it.

best.
Willy

[curiouslady1]

I second the suggestion to see the doc right away.  No telling if you have picked up some other infection or having heart problems.  

[yodennis]

Hector: I thought I had read (I glean more than read right now) that there was a study that revealed 8 weeks of Incivek "may" be as effective as 12 weeks for a certain HCV population (the study had no cirrhotics included as I remember). I'm presuming by your above statement that while this may be the case with Incivek if all the therapies, e.g., Peg and Riba were discontinued that this would not be the case. Sorry for the ambiguity.

[dointime]

A woman in my group on the Vertex trial of the triple tx stopped everything at week 10 because of the rash and she went on to SVR.  She was in her 20's, started with a low vl and had not had hepC for long.  That is all I know about her.

Good luck
dointime  

[copyman]

If you were doing just SOC drugs then i would say there was almost no chance of SVR. But with telaprevir and 4 week UND you should have a very good chance of SVR.
best of luck

[HectorSF]

I am assuming that all meds were stopped. Including both peg-IFN & Riba.
"I got to 2 days before my 10th week and had to stop everything."

If only the Incivek was stopped but peg-IFN & Riba was continued you are correct that the SVR rate would only drop 9% compared to treating for 12 weeks with Incivek. The issue is the peg-IFN and Riba the treatment duration. It must be long enough to eradicate any remaining virus variants, including higher level resistant variants that the Incivek doesn't act upon. (Remember the Incivek only stops the replication of the wild-type and lower level resistant variants.

For more info see the FDA ?Antiviral Drugs Advisory Committee, April 28, 2011, Briefing Document" Section - 5.5 "Rationale for Treatment Duration".

Cheers
Hector

[lynda607]

I wouldn't say a very good chance even with a UND at 4 weeks.  IMO, it would be slight.  Quitting all drugs at 10 weeks means resistant variants will not be eliminated because there is no additional exposure of P/R.  

[willbb]

A chance possibly ,however because there was no combo DAA used as lynda says resistance very well may be  an issue.

http://www.natap.org/2011/HCV/060911_02.htm

As a result of the enhanced viral decay caused by the high antiviral effectiveness of telaprevir, we predict that if drug resistance could be avoided by using an appropriate combination of antiviral agents, treatment duration needed to clear HCV might be dramatically shortened. Indeed, we predict that in 95% of fully compliant patients, the last virus particle should be eliminated by week 7 of therapy. If the remaining infected hepatocytes act as a potential reservoir for the renewal of infection, no more than 10 weeks of treatment should be sufficient to clear the infection in 95% of fully compliant patients. However, if patients miss doses, treatment duration would need to be extended.

[hepcexperiment]

I hhad geno 1 that cleared at 4 weeks. biopsy showed level 2? no cyrossis no symptoms very mild case at times undetectible. dr did DNA test that showed i would have 90% cure rate on incivek

[hepcexperiment]

i am bipolar and have been on Lamictal 150 mg stabilized since 2002. I also take clonopin for anxiety and sleep during this treatment.

[hepcexperiment]

thank you for all replies. last night had spontaneous bleeding (am 52 and possibly perimenopausal) and about 4 clots the size of a small parakeet fell out of my body. was very scared and called dr expecting after hrs service that would page him  but instead got girlfriend who rolled over in bed and talked to him and i could hear him say "tell her to go to emergency rm" and then she would not let me talk to him and refused to make an appt for me to see him next day. then she proceeeded to dispense medical advice ! so unprofessional. She's sleeping with the guy, not a doctor, and she wont let me speak with the dr who put me on this toxic treatment. I need to report him and find a new dr fast. am in new yor if any recommendations.

[willbb]

How long have you been off all treatment meds and when was your last viral load PCR?
Will

[Willy50]

Keep in mind that we don't even know the OP's genotype.  We don't actually know when they cleared other than they cleared at a week 4 PCR.  Some doctors are doing them earlier but I don't think we actually know when clearance occurred.

One of the earliest members here in Prove 1 was clear at day 3.  Some people respond to TX very well.  In theory those people should be able to treat for a shorter period of time.  The trial arm I spoke of only had 20 people and after a few drop outs/discontinuations the final numbers being analyzed was on the order of 16 or 17 people.
Some people did not hit the UND marks at 4 and 10 weeks (I checked, that was the protocol).  The final numbers they analyzed were meager but the reported....at 2007 EASL;

"* Six of 9 patients in one treatment arm who completed 12 weeks of treatment, and who had achieved an RVR as defined by the study protocol (<10 IU/mL), continued to have undetectable HCV RNA 20 weeks after stopping all treatment (“SVR20”)."

Keep in mind that this was about the first dosing of triple therapy and people were scared.  One person discontinued after only one dose, it kind of skews the stats.

willy

[lynda607]

The OP has to be a genotype 1 for insurance to pay or the doctor is prescribing Incivek off label and the majority of people could not pay for it out of pocket.  Vertex would not provide free or reduced cost to anyone other than a genotype 1.

It took Vertex many years of clinical trials to come up with a treatment protocol which that provides optimal results.  It's highly unlikely hepcexperiment will succeed with only 10 weeks of therapy.

[curiouslady1]

If you are going through menopause, as it appears you are, and you are bleeding heavily you will inevitably have some anemia just from that.  Your other symptoms are complicated because of the menopausal symptoms as well.  Your depression, weight gain, bloatedness, fatigue, and cognitive problems all would be complicated by the hormonal changes you are going through.  On top of everything including a pre-existing psychiatric condition, you have been taking very powerful drugs.  As someone who also had heavy bleeding and other symptoms around this time, I would say that the best thing I did for myself was to get to a really good ob-gyn and get those symptoms under control.  Time enough for you to worry yourself over the hepatitis and whether it is returning or not; you have much more important things to deal with right now.  I think once your system gets into better balance from what the doctor might give you to get through this time, your head will clear and you will be better able to decide what to do next.

[Willy50]

Until a few moments ago there was only one post by the OP I checked, it was her first post).  I'm not drawing any conclusions.  The information you just posted I am not seeing in this thread, even in the OP's subsequent posts.

My understanding is that a doctor may have stopped the TX due to the sides reported in the first post.  I don't believe this was the plan, but an unfortunate outcome; discontinuations happen.

In my first post I wrote;
"The odds are not great at 10 weeks but i wouldn't say impossible."

I then provided some text taken from a Vertex 2007 EASL report on Prove 1 outcomes to fill out what I couldn't quite remember perfectly.  

But yes..... a reasonable percentage were able to SVR after only 12 weeks of triple therapy, although the trial arm only had 20 participants to start.  Some didn't hit the 4 and 10 week UND marks and therefore due to trial design continued to treat; not eligible to stop. A reasonable number that did hit those guidelines and who chose to stop at 12 weeks did achieve a SVR20.  

willy

[can-do-man]

Not sure you can compare this to the 12 weeks, theres a total of 84 days of triple therapy with 12 weeks where this person only did a total of 68 days of therapy......... Two weeks might to seem like much in a 48 week course but in this case its really alot.

All that said, could someone SVR? Sure, are the odds in ones favor? No.

For people reading this unless your like this OP and don't have much of a choice i would not recommend trying this.

Good luck hepc

[can-do-man]

Opps..... Two weeks might NOT seem

[lynda607]

I realize we didn't see the OP post her genotype but it's quite reasonable to assume that she is genotype 1 given Incivek and Victrelis are only approved for genotype 1.

Perhaps the OP will provide her genotype and an update on her UND status in the future.